Further launch on the agenda for CLS issuance

The following material does not constitute an offer but should be seen as a marketing of Clinical Laserthermia Systems (CLS). Accordingly, the material does not necessarily contain all the information for an investment decision and has not been reviewed or approved by the competent authority in accordance with the rules of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017. For complete information and terms and conditions of the ongoing rights issue, investors are advised to read the EU growth prospectus approved by the Swedish Financial Supervisory Authority on 20/6/2023 and which is available on the CLS website, https://clinicallaser.se/.

The First North-listed medical technology company Clinical Laserthermia Systems (CLS) develops and sells products for minimally invasive laser ablation treatment. A treatment that involves destroying tissue that generates disease in the body by raising the temperature of the cells using high-energy laser light. The treatment performed with CLS products is carried out without surgery and thus in most cases without the patient being sedated. A quick return home and avoidance of complications is the major advantage for the patient, with a simultaneous opportunity for lower costs for healthcare.

Commercialization underway

CLS is in the midst of commercializing the new generation TRANBERG-products, with a focus on urology, neurosurgery and oncology. Last year, the company had sales of just over SEK 6 million and the goal is for those sales to increase significantly in the future. In 2025, CLS hopes to have sales of around SEK 100 million, which would mean that the business achieves break-even on EBITDA.

This growth is expected to come primarily from the urology segment, where it is targeting a large and growing market. In 2019, the market for minimally invasive prostate cancer treatment in the US and Europe was estimated at approximately 35 billion USD and it is expected to grow by 12 percent annually until 2027.

Several advances in urology

In urology, CLS has recently announced several advances. Among other things, the last patient in the US-based Phase I clinical trial, which uses the CLS TRANBERG Thermal Therapy System in combination with Focalyx Fusion for focal laser ablation of low- and intermediate-risk prostate cancer, received treatment and patient follow-up is ongoing.

CLS has also been extremely productive in signing partnership agreements. It has signed such an agreement with Soteria Medical to jointly market and sell the companies' combined product portfolios for MR image-guided prostate procedures in markets outside the US.

The company also recently entered into a non-exclusive distributor agreement with the company Real Fusion and thus enters the urology market in the Baltic states.

The company also entered into a letter of intent with HALO Precision Diagnostics in the US on a post-marketing study with up to 25 patients to evaluate the TRANBERG Thermal Therapy System for ultrasound-guided treatment of prostate cancer. Following evaluation of the study, the counterparty intends to enter into discussions with CLS to purchase the system for use in some of its 16 clinics.

Research collaboration with NIH

CLS has also initiated a research collaboration with National Institutes of Health Clinical Center (NIH CC) in the USA. NIH will evaluate the TRANBERG Thermal Therapy System for ultrasound-guided treatment of prostate cancer. The agency intends to purchase the materials needed for the study from CLS.

CLS also signed an agreement with American AVANT Concierge Urology regarding packaged services related to ultrasound-guided focal laser ablation in patients diagnosed with localized prostate cancer. The agreement includes use of the TRANBERG Thermal Therapy System, sterile consumables, training, and on-site clinical and technical support for AVANT physicians and staff, for a fee per treatment.

In addition, now implement Unio Health Partners a clinical phase-I study where the use of the TRANBERG Thermal Therapy System is image-guided with the unique micro-ultrasound system ExactVu which offers a higher resolution and thus greater detail in the image.

Continued advances in neurology

A lot has also happened in the neurological segment. After last year's FDA-approval in neurosurgery, CLS received a first order of SEK 5,5 million from its American partner Clearpoint Neuro. For the approved system, which has been given the trademark Clearpoint Prism Neuro Laser Therapy System and which is used with MR image guidance, is now undergoing a limited market launch for the treatment of tumor disease and drug-resistant epilepsy in the US market.

Back home in Sweden, all five glioblastoma patients in the media-highlighted study at Skåne University Hospital have been safely treated. The study has been expanded to include up to 10 additional patients and the first patient in the expanded study has already been treated. See BioStock's interview with CLS CEO Dan Mogren regarding the study here.

Issuance to maintain pace of establishment

With full focus on market establishment to reach break-even on EBITDA, CLS is now carrying out an approximately 84 percent guaranteed rights issue, aiming to raise just over SEK 135 million. The issue is of units that also include warrants of series TO 6 B, which during February 2024 can provide the company with a maximum of approximately SEK 54,3 million.

The proceeds will be used to accelerate the ongoing market launch and enter into additional clinical collaborations. A portion of the funds will also be used for full repayment of loans, which will strengthen the company's capital structure.

The subscription period runs until July 3, 2023.

The offer in summary

You can read more about CLS here.